It is generally recognized that high blood cholesterol concentrations provide a significant risk factor in heart disease. It is also generally recognized that eating foods high in saturated fats, like many red meats, may contribute significantly to increased blood cholesterol concentrations in humans. Correspondingly, the increased blood cholesterol concentration in humans seems to have a direct positive correlation with coronary heart disease. Accordingly, there is a continuing and real interest in decreasing the intake of food substances that have high cholesterol content. Thus, there has been in the past years a significant health trend away from red meat, milk products, and eggs. Accordingly, there is a continuing and real need to develop techniques for decreasing cholesterol concentrations in these foods.
Cholesterol reductase is a known enzyme that catalyzes the chemical reduction of cholesterol to coprostanol. However, heretofore, it has been believed and found that cholesterol reductase is present only in certain bacteria. In my earlier filed application, it was reported that it had been discovered that cholesterol reductase is present in certain green plant parts, particularly the leaves of green leafy plants, such as soybeans, corn, and cucumbers. It is believed that in my earlier application we were the first ever to discover and take advantage of the existence of cholesterol reductase in green plant parts.
In my earlier application, the invention was premised upon a method of decreasing cholesterol concentration in meat by administering to meat animals just prior to slaughter a substantial dose of cholesterol reductase. This can be thought of as an "indirect" means of treating cholesterol concentration in humans. The present application is premised upon a more direct route that involves oral capsule administration of cholesterol reductase to humans.
It is a primary objective of the present invention to provide an oral method of administration of cholesterol reductase to humans such that the delivery system bypasses the stomach and releases cholesterol reductase in the small intestine to convert cholesterol in the lumen of the small intestine to coprostanol, which is poorly absorbed.
Another objective of the present invention is to administer to humans via the proximal small intestine, cholesterol reductase to convert cholesterol to coprostanol.
Another objective of the present invention is to provide a delivery system for cholesterol reductase that is resistant to degradation by the acid and the proteolytic enzymes of the stomach such that it does not release the within-contained cholesterol reductase until the capsules, pills, or the like have passed from the stomach into the small intestine.
A further objective is to use a substance to protect the cholesterol reductase from the proteolytic activity in the small intestine.
An even further objective of the present invention is to decrease the health risk of people that use meats and other animal products used as food, such as swine, poultry, fish, eggs, and milk products, by decreasing the cholesterol concentration within the body of the food product consumer.
The method and means of accomplishing each of the above objectives as well as others will become apparent from the detailed description of the invention that follows hereinafter.